(60 days)
The Cynosure SculpSure™ is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.
The Cynosure SculpSure is a diode laser system. The main components of SculpSure are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which is used to deliver laser energy to subcutaneous tissue layers.
Acceptance Criteria and Study Details for SculpSure Device
The SculpSure device is intended for non-invasive lipolysis to reduce fat in specific body areas. The following information details the acceptance criteria and the study that demonstrated the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effectiveness - Photographic Assessment | Blind evaluators able to identify 86% of post-treatment photographs (Back: 91%, Outer Thigh: 87%, Inner Thigh: 83%). |
| Effectiveness - Fat Reduction (Ultrasound) | At 12-week post-follow-up, average 8.6% normalized fat reduction (Back: 10.6%, Outer Thigh: 7.2%, Inner Thigh: 8.0%). All treatments had a *p-value of X% fat reduction"). Instead, it reports the observed performance and concludes that the results demonstrate safety and effectiveness for substantial equivalence. The reported performance values in the table are the actual results from the study.) |
2. Sample Size and Data Provenance for Test Set
- Sample Size: A total of 168 subjects, making up 214 treatment areas, were enrolled in the study.
- Back: 55 subjects / 55 treatment areas
- Outer Thigh: 52 subjects / 52 treatment areas
- Inner Thigh: 61 subjects / 107 treatment areas
- Data Provenance: The study was a prospective, controlled study conducted at 3 study centers. The specific country of origin is not explicitly stated, but it can be inferred to be within the US given the submission to the FDA.
3. Number of Experts and Qualifications for Ground Truth
The document mentions "blind evaluation of pre and post treatment (12-week) photographs," and "blind evaluators were able to identify 86% of the post treatment photographs." However, the number of experts used to establish the ground truth for the test set and their specific qualifications are not provided in the provided text.
4. Adjudication Method
The document states "blind evaluation of pre and post treatment (12-week) photographs." This indicates a degree of blinding. However, the specific adjudication method (e.g., 2+1, 3+1, none) is not explicitly stated for establishing ground truth or for resolving discrepancies in photographic evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done comparing human readers with and without AI assistance. The study evaluated the device's efficacy in non-invasive fat reduction.
6. Standalone (Algorithm Only) Performance
This device is a laser system (SculpSure), not an AI algorithm. Therefore, the concept of "standalone (i.e., algorithm only without human-in-the-loop performance)" does not apply to this medical device. The study evaluates the performance of the physical device as used by a human operator.
7. Type of Ground Truth Used
The efficacy of the treatment was assessed using a combination of:
- Photographic assessment: Blind evaluation of pre and post-treatment photographs.
- Ultrasound imaging: Measurement of percentage change in adipose tissue thickness from baseline to 12-week follow-up.
8. Sample Size for the Training Set
The document describes a clinical study to evaluate the device's safety and efficacy for specific body areas. This study serves as the primary evidence for the device's performance. The concept of a "training set" typically applies to machine learning models. For a physical device like SculpSure, the provided documentation does not refer to a separate "training set" in the context of clinical studies.
9. How the Ground Truth for the Training Set was Established
As mentioned above, the concept of a "training set" as it applies to software or AI algorithms is not directly relevant here. The "ground truth" for the clinical study's effectiveness was established through the objective measurements of ultrasound imaging for fat reduction and the subjective yet blinded assessment of photographic changes.
§ 878.5400 Low level laser system for aesthetic use
(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.